Post Office Box 1070
Frankfort, Kentucky 40602
(502) 875-2428 phone (502) 875-2845 fax
December 31, 2003
Michael S. Mullins
Division of Waste Management
14 Reilly Road
Frankfort, Kentucky 40601 By email to:
Re: Proposed Regulation & Incorporated Guidance
401 KAR 100:030 Remediation Requirements
Dear Mr. Mullins:
These comments are submitted on behalf of the Board and membership of the Kentucky Resources Council, Inc., a nonprofit environmental advocacy organization incorporated under the laws of the Commonwealth of Kentucky and dedicated to prudent use and conservation of the natural resources of the Commonwealth.
KRC members include numerous individuals who reside, work, and live in areas that have been adversely affected by releases of hazardous substances, pollutants and contaminants into the environment. KRC members, and indeed the public at large, rely on the Natural Resources and Environmental Protection Cabinet and the standards and procedures under KRS 224.01-400 to protect their legitimate interests in assuring that those releases are properly remedied and that the statutory goals and long-term interests of the Commonwealth in assuring the protection of the public health and environment are not compromised in an effort to improve the ledger sheet ?bottom line or in a misguided effort to spur short-term economic development by externalizing and shifting to future generations and adjoining landowners the full costs of non-remediation.
KRC has reviewed the proposed remediation requirements and accompanying guidance documents, and in general KRC supports the regulatory package that has been proposed by the Cabinet. KRC does so, however, with reservations, and with grave concern that if the Cabinet weakens or departs from the proposed regulations in certain critical areas, the package will become underprotective of the public health and environment and inconsistent with the statutory mandates of KRS 224.01-400.
The adoption of the proposed remediation requirements by the Cabinet is no insubstantial task, and the agency is to be commended for the diligence with which it has approached this task, and the flexibility it has shown. KRC approaches these regulations with a degree of caution and a belief that, with certain changes, the regulations provide a sound framework for protecting human health and the environment in remediation actions.
The adoption of remediation requirements is not a task lightly undertaken, and is one in which substantial public policy issues are implicated.
It must be understood at the onset that these standards and requirements are not, as has bee misunderstood by some, applicable only to mildly contaminated abandoned sites where an effort is being made at urban revitalization (so-called brownfields sites). Industry successfully broadened the scope of this program to include sites that were being proposed for inclusion by the same company that had contaminated the land, air or water resources in the first place. The sites to which these standards and requirements will apply include the full gamut of sites where hazardous substances have been released into the environment from the most simple site to the most complex, and including those abandoned or blighted former commercial or industrial sites for which no responsible party remains and the many seriously contaminated sites still actively used or held by companies that are seriously contaminated, and for which there is no intention by the company to divest themselves of the land or to reuse it in any beneficial manner.
The law mandating adoption of these regulations expressly provides for flexibility in development of remediation options for managing hazardous releases in place, but allows no cutting of corners, no regulatory or linguistic sleight-of-hand by which dirty becomes clean, but instead demands that the standards for all sites be protective of public health and the environment.
In approaching the establishment of remediation standards for contamination, humility in the face of substantial scientific uncertainty is advisable, and conservatism in the selection of remedial standards is justified. There are substantial uncertainties in the toxicological field regarding the standards at which chronic low-dose exposure to toxicants produce no adverse effects, and indeed little understanding of the mechanisms that produce the adverse physiological effects. Particularly for older chemical compounds whose market entry predated federal laws, little data exists concerning both cancer and non-cancer neurological physiological effects. Of the over 70,000 chemicals in the market, complete human health data exists for about 2%, partial data for about 14% and less about the remainder. Even less is known about ecological impacts of single toxicant exposure. The reality is, also, that exposure to these compounds does not occur in a vacuum, but instead, these sites involve a mix of several toxicants, and the additive, synergistic and other effects of multiple chemical exposure are but dimly understood. Understanding of additive and synergistic effects is in its relative infancy, and ATSDR has just released an assessment of Joint Toxic Action of Chemical Mixtures reflecting the uncertainties in understanding such interactions.
While there may be commenters seeking to weaken the remedial goals in order to accommodate less rigorous remediation, the long-term interests of the responsible parties and the public are not served by such actions. The costs of inadequate characterization and remediation are profound, and adversely affect the program applicant, subsequent purchasers, neighbors, and the next generation who will inherit our mistakes. To the extent that we shift costs of non-remediation or improper management off-budget by issuing letters absolving responsible parties of remediation responsibility, we limit the land utilization of the next generation and shift to that generation the costs of second-generation remediation. A contaminated property that is today poorly characterized and left unremediated because it will be reused as a parking lot is doomed to remain utilized at that low-end of value, because the next generation will have to pay for remediation to higher uses and we will have closed the door to responsible party funding of that remediation. Beyond the inequities of shifting costs off-budget and saddling the next generation with costs because we have inoculated the polluters from responsibility for their wastes, shoddy remedial investigation and inadequate remediation standards will not meet the program goals of revitalizing contaminate properties for new use.
During the regulatory development process, KRC outlined several key principles for the development of standards and remediation requirements. Those standards included:
1. The coverage of the regulation must be consistent with the scope of the statute, which directed the development of remediation standards for all KRS 224.01-400 sites.
2. The standard for protection of human health and the environment should be defined as a cumulative risk of no greater than 10 6 and a hazard index of no greater than 1.
3. If the option of managing a release in place is chosen, the protection standard must be met at all points of potential exposure and within the managed site boundary. All pathways are to be managed on the property to prevent exposure, and any plumes must be arrested.
4. The management requirements must be enforceable by the Cabinet.
5. For removal and no action options (i.e. where no management is proposed, whether passive or active) the standard for protection must be met in the media itself, since without any restriction the assumption must be that future exposure may occur throughout the media.
6. Screening for the concentrations of hazardous substances should, as directed by the General Assembly, be in accordance with EPA Region IX standards, done according to the guidance and accepted screening procedures. Screening undertaken in accordance with those requirements reflects a legislative judgment that the site, as a preliminary matter, is not of categorical regulatory concern, but does not constitute a certification of suitability of the site or compromise the Cabinets authority to require more remediation in order to meet the remedial goals of protecting public health and the environment.
7. A site cannot be managed to reduce the contaminant levels to below screening levels, since those levels are concentration-based rather than exposure levels.
8. Ambient background, while typically applicable to inorganics, may in rare circumstances include natural organics (such as kerogen in Chattanooga Shale, etc.). Ambient cannot include anthropogenic activities unless they are regional in nature, so that the use of foundry sand for fill, or lead scrapings from homes, would not be considered ambient background. In most cases the risks, if any, will fall below the levels of concern or can be readily managed in place, but the goal should not be to hide releases under the rug of ambient background, but instead to thoroughly assess site conditions and to manage them to encourage stable redevelopment. The scrapings of lead from homes, bridges, etc., is a release, not an ambient condition. Organics as ambient conditions would be the exception rather than the rule.
9. All sites should be placed on the inventory, and cross-referenced by owners, location, the type of activity, and compounds of concern those sites without a permanent remedy (i.e. removal) should be revisited every five years to determine if the management and land use assumptions remain valid.
In light of these principles and against the backdrop of concern regarding the establishment of remediation requirements and standards, KRC offers these specific comments:
1. Ambient Background Definition
There has been concern expressed regarding the definition of ambient background. KRC supports the idea that the presence of a substance that is from an identifiable release cannot be considered background, and urges that the concept be retained in order to prevent a release from site A from becoming background on an other site.
In order to address the concern expressed by Shield Environmental at the November 19, 2003 seminar, the phrase not attributable to an identifiable release could be clarified to read not attributable to a release from an identifiable source. Similarly, the phrase not attributable to activities on the property contained in the Guidance Document on Ambient Background (p. 1) should be removed and replaced with not attributable to a release from an identifiable source or not traceable to a discernable release in order to prevent off-site identifiable releases from becoming on-site background.
In defining ambient background for purposes both of sampling to determine ambient conditions and to define the level of remedial responsibility, releases around buildings from paint scrapings or from past disposal of contaminated sands (foundry sands) would not be considered ambient background since they are the result of releases from wastes beneficially and intentionally disposed of on site (any more than, for example, metals released from fly ash undermanaged today would be considered ambient background), nor would releases of lead from automotive exhausts along roadways be considered ambient background. Allowing past discernible releases to be blended into background rather than being considered historic releases that should be remedied, has the effect of sweeping risks under the rug and cheapening the goals of protecting human health.
KRC supports the proposed adoption of a standard of no greater than 50 mg/kg for lead in surface soils for unrestricted use as the applicable, relevant and appropriate requirement for protection of public health, though KRC believes that even at 50 ppm from surface soil, there may be circumstances in which the total risk to children may exceed appropriate health-based standards.
There is perhaps no more troublesome an area than the setting of remediation standards for lead. According to ATSDRs toxicological profile on lead, the average child ingests between 20 and 50 milligrams of soil per day, and a pica child may ingest 5,000 milligrams or more of soil per day.
According to the ATSDR:
If the soil contains 100 ug/g of lead, an average child may be exposed to 5 ug of lead per day from this source alone, and a pica child may be exposed to more than 100 times that amount. At the EPA's Soil Screening Guidance concentration of 400 mg Pb/kg soil, a 13 kg child who consumes 5 g of soil during a pica episode would have a dose from soil of 0.2 mg Pb/kg of body weight, which is 10 times the nonlethal toxic dose. Yard soil containing lead concentrations >500 mg/kg has been associated with a mean PbB 10 ug/dl in children 6 to 71 months of age in a multi-site study.
While KRC understands that the use of the Region IX numbers is directed by the legislature, it is apparent that if parties utilize the Region IX screening standards of 400 ppm concentration of lead in surface soils for unrestricted use, and do not remediate sites where there will be uncontrolled access to lead-contaminated soils by children to a more rigorous concentration-based standard, harm to the health of exposed children is not merely possible but likely.
As KRC understands the genesis of the Region IX number (400 ppm), it is based in large part on the interactive IEUBK model developed by EPA which assumes that, for 95% of the exposed child population, a concentration of 400 parts per million of lead in outdoor soil will result in a blood lead level of no greater than 10 micrograms per deciliter (10 ug/dl) in those children. Stated alternatively, for 5% of the children exposed to soil lead levels at 400 mg/kg concentration of lead in addition to other typical pathways of exposure such as food, water, and indoor dust, their blood lead levels will exceed the current health standard of 10 ug/dl of blood lead.
The 10 ug/dl / 400 ppm soil concentration standards, which is the current health standard, are not a standard where no observable adverse effects are detectable, and in this manner are unlike the other Region IX Preliminary Remediation Goals that are calculated on a NOAEL (no observable adverse effects level). Instead, the 10 ug/dl blood lead level is an observed-effects level, at which it has been documented that significant adverse neurological and behavioral effects on children occur.
According to peer-reviewed health literature, adverse neurological and behavioral effects are observable in children at concentrations significantly lower than 10 ug/dl, so that the use of the 400 ppm standard will not result in satisfaction of the statutory mandate of protection of human health and the environment. See, for example, Rogan and Ware, Exposure to Lead in Children How Low is Low Enough?, New England Journal of Medicine April 17, 2003; (documenting adverse developmental effects at 3 ug/dl blood lead levels); Canfield, Henderson, Cory-Slechta, Cox, Jusko, and Lanphear, Intellectual Impairment in Children with Blood Lead Concentrations below 10 ug per Deciliter, New England Journal of Medicine, April 17, 2003 (concluding that blood lead concentrations even below 10 ug per deciliter are inversely associated with childrens IQ scores at 3 and 5 years and associated declines in IQ are greater at these concentrations than higher concentrations, suggesting that more U.S. Children may be adversely affected by environmental lead than previously estimated.) The use of a default value of 50 ppm may be protective, and at least is eight times more conservative than the 400 ppm standard that has been documented as not being protective. In the absence of a default value such as 50 ppm, the applicant should be required to develop a NOAEL standard for lead using the IEUBK model, incorporating soil ingestion values for normal and pica children.
While there has been an effort by some to force the Cabinet to accept more generous soil lead levels, that effort is both of questionable morality and even more questionable health science, and is foolish from a purely economic perspective. The recent decision in Jefferson County imposing a substantial judgment against a public agency for soil lead poisoning reflects that the courts will, in those cases where so-called lead-free environments in fact cause adverse health effects, impose economic costs far in excess of those that proper remediation would have imposed had the contaminants been properly and conservatively managed in the first instance.
3. Target Risk
The proposition that the hazard index of 1.0 for non-cancer endpoints should be changed to 1, in order that the risk assessor may use a value of up to 1.49 as the hazard index, is both inappropriate and inconsistent with the concept of the hazard index and the reference dose.
The reference dose (RfD) is used as a threshold dose below which non-cancer adverse effects of chemical are not expected. Altering this threshold upwards by allowing up to 49% higher toxicity value than the no-effect threshold distorts the risk analysis and will result in instances in which exposures causing harm will occur due to the rounding down of adverse effect-levels.
The use of a hazard quotient (for one chemical) or hazard index (for multiple chemicals) of 1.0 is the standard ratio at which adverse effects are anticipated. As noted by Stelljes in Toxicology for Non-Toxicologists, which was distributed for informational purposes by participants in the task force, the hazard index/quotient of one is used, and if the ratio of the estimated dose to the reference dose is above one, the estimated dose may result in toxicity. Altering the ratio to 1.49 will result in masking potential non-cancer toxicity. As noted again by Stelljes, because the goal of risk assessment is to protect all possible receptors, this target of one ensures that even sensitive members of a population (e.g. infants) are safe with regard to chemical exposure. Commenters must justify how it is that increasing the ratio by 49% will remain equally protective.
In subsection 3, the owner of the property should be required to conduct full characterization and remediation . . . .
In subsection 4, the Cabinet should make explicit its ability to require further characterization of a property and remediation of any release pursuant to . . . .
In subsection (1), the applicant should be required to disclose known or ascertainable information concerning ownership of the property and site rather than of the site.
In subsection (2) the scale of the map should be specified.
The phrasing of subsection (2)(a)b is supported, since the statute demands consideration of not merely the additivity of contaminants but the full range of the synergistic interactions of chemicals with each other and with the media into which they are released.
The use of the phrase point of exposure in Section 8(3)1a in the context of demonstrating that no action is necessary to protect human health and the environment, raises a concern that the Cabinet is considering the point of exposure to be less than the entire tract of land. In an uncontrolled environment in which substances will remain in situ, it must be assumed that the substances may come into direct contact through subsequent site disturbance or creation of pathways of exposure, since there are no management mechanisms employed to prevent such future exposure. Clarification is sought that for no-action alternatives, the assumption is that the concentration throughout the media will not exceed target levels of 10-6 and a hazard index of 1 because of the lack of institutional or other controls.
In establishing the no action background levels for inorganics under Section 8(3)(a)1b, the ambient levels against which the necessity for action must be measured should be site-specific rather than generic ambient levels. No one should be allowed to leave in place inorganic contaminants higher than site-specific background using generic state-generated numbers, particularly when it is acknowledged that those numbers include contaminated sites. Similarly, in Section 8(3)(c), no one should be allowed to use generic ambient numbers to leave concentrations of contaminants in place in a restored site that are higher than ambient background for that property. In both cases, where the ambient background levels are above target risk levels and the site is proposed to be approved for no action or as restored, the Cabinet should maintain a record documenting that the ambient conditions are above target risk levels in order that the subsequent purchasers be forewarned that action might need to be taken outside of the 01-400 context in order to make the site safe. Further, to the extent that the site is owned or managed by a public agency, that agency may be under a statutory obligation to disclose that site condition or status even though the risks are outside of the 01-400 remediation ambit.
In 8(3)(a)2, the end phrase on the property should be removed, consistent with the idea that ambient background is that which does not come from a release from a discernable source regardless of whether that source is on or off the property.
In 8(3)(a)4a, the word additive must be removed and replaced with cumulative since the statute demands consideration of more than just additivity.
In Section 8(3)(b)1, KRC strongly supports the incorporation of the concept that in all cases, management must include in all cases the containment of the release and either eliminating the pathways or reducing the exposure to meet the health-based and ecological goals.
In Section 8(3)(b)3a and b, KRC opposes an inspection frequency that is any less frequent than annual, and believes that the default should be more rigorous than yearly.
Thank you for your consideration of these comments.